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YD Bio Business Partner EG Biomed Achieves CAP Accreditation, Advancing U.S. Clinical Testing Capabilities 

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YD Bio (Nasdaq: YDES) announced that its business partner EG BioMed achieved CAP accreditation for its CLIA-certified laboratory in Bothell, Washington (CLIA Certificate #50D2316600) on October 10, 2025. CAP accreditation, alongside existing CLIA certification, confirms laboratory quality standards and strengthens EG BioMed’s ability to deliver advanced laboratory-developed tests (LDTs) supporting YD Bio’s DNA methylation-based pancreatic and breast cancer detection programs in the U.S.

YD Bio highlighted that this accreditation positions the companies to expand their diagnostic portfolio for early cancer detection and monitoring. EG BioMed’s Chief R&D Officer presented new circulating cell-free DNA biomarker findings at AACR (September 28–October 1, 2025) relevant to metastatic pancreatic cancer monitoring.

YD Bio (Nasdaq: YDES) ha annunciato che il suo partner commerciale EG BioMed ha ottenuto l'accreditamento CAP per il suo laboratorio certificato CLIA a Bothell, Washington (Certificato CLIA n° 50D2316600) il 10 ottobre 2025. L'accreditamento CAP, insieme alla certificazione CLIA esistente, attesta gli standard di qualità del laboratorio e rafforza la capacità di EG BioMed di fornire test sviluppati in laboratorio (LDT) avanzati che supportano i programmi di rilevamento del cancro al pancreas e al seno basati sulla metilazione del DNA di YD Bio negli Stati Uniti.

YD Bio ha evidenziato che questa accreditazione posiziona le aziende per espandere il loro portafoglio diagnostico per l'individuazione precoce del cancro e il monitoraggio. L'A.D. di R&S di EG BioMed ha presentato nuove scoperte sui biomarcatori di DNA circolante libero al AACR (28 settembre – 1 ottobre 2025) rilevanti per il monitoraggio del cancro al pancreas metastatico.

YD Bio (Nasdaq: YDES) anunció que su socio comercial EG BioMed logró la acreditación CAP para su laboratorio certificado CLIA en Bothell, Washington (Certificado CLIA n.º 50D2316600) el 10 de octubre de 2025. La acreditación CAP, junto con la certificación CLIA existente, confirma los estándares de calidad del laboratorio y fortalece la capacidad de EG BioMed para entregar pruebas desarrolladas en laboratorio (LDT) avanzadas que respaldan los programas de detección de cáncer de páncreas y de mama basados en la metilación del ADN de YD Bio en Estados Unidos.

YD Bio destacó que esta acreditación posiciona a las empresas para expandir su cartera diagnóstica para la detección temprana del cáncer y el monitoreo. El Director de I+D de EG BioMed presentó nuevos hallazgos sobre biomarcadores de ADN circulante libre en AACR (del 28 de septiembre al 1 de octubre de 2025) relevantes para el monitoreo del cáncer de páncreas metastásico.

YD Bio (Nasdaq: YDES)가 비즈니스 파트너인 EG BioMed이 볼트헬(V Bothell), 워싱턴주에 위치한 CLIA 인증 실험실에 대한 CAP 인증을 2025년 10월 10일 달성했다고 발표했습니다( CLIA 인증서 #50D2316600 ). CAP 인증은 기존 CLIA 인증과 함께 실험실의 품질 표준을 확인하고 미국에서 YD Bio의 DNA 메틸화 기반 췌장암 및 유방암 탐지 프로그램을 지원하는 고급 실험실 개발 테스트(LDT)를 제공하는 EG BioMed의 능력을 강화합니다.

YD Bio는 이 인증이 양사가 조기 암 진단 및 모니터링을 위한 진단 포트폴리오를 확장하는 데 도움이 될 것이라고 강조했습니다. EG BioMed의 R&D 책임자는 AACR(2025년 9월 28일~10월 1일)에서 순환 자유 DNA 바이오마커에 대한 새로운 발견을 발표했고 이는 전이성 췌장암 모니터링과 관련이 있습니다.

YD Bio (NASDAQ : YDES) a annoncé que son partenaire commercial EG BioMed a obtenu l'accréditation CAP pour son laboratoire CLIA certifié à Bothell, Washington (Certificat CLIA n° 50D2316600) le 10 octobre 2025. L'accréditation CAP, aux côtés de la certification CLIA existante, confirme les normes de qualité du laboratoire et renforce la capacité d'EG BioMed à fournir des tests développés en laboratoire (LDT) avancés soutenant les programmes de détection du cancer du pancréas et du sein basés sur la méthylation de l'ADN de YD Bio aux États-Unis.

YD Bio a souligné que cette accréditation positionne les sociétés pour étendre leur portefeuille diagnostique pour la détection précoce du cancer et le suivi. Le Directeur R&D d'EG BioMed a présenté de nouveaux résultats sur des biomarqueurs d'ADN circulant libre lors de l'AACR (du 28 septembre au 1er octobre 2025) pertinents pour le suivi du cancer du pancréas métastatique.

YD Bio (Nasdaq: YDES) gab bekannt, dass sein Geschäftspartner EG BioMed die CAP-Akkreditierung für sein CLIA-zertifiziertes Labor in Bothell, Washington (CLIA-Zertifikat Nr. 50D2316600) am 10. Oktober 2025 erreicht hat. Die CAP-Akkreditierung bestätigt zusammen mit der bestehenden CLIA-Zertifizierung die Qualitätsstandards des Labors und stärkt die Fähigkeit von EG BioMed, fortschrittliche Laborentwickelte Tests (LDTs) bereitzustellen, die die DNA-Methylierungs-basierten Programme zur Erkennung von Bauchspeicheldrüsen- und Brustkrebs in den USA unterstützen.

YD Bio hob hervor, dass diese Akkreditierung die Unternehmen positioniert, ihr diagnostisches Portfolio für eine frühzeitige Krebsdiagnose und -überwachung auszubauen. Der Forschungs- und Entwicklungschef von EG BioMed präsentierte neue Erkenntnisse zu Biomarkern aus zirkulierender freier DNA auf der AACR-Konferenz (28. September – 1. Oktober 2025), relevant für die Überwachung von metastasierendem Bauchspeicheldrüsenkrebs.

YD Bio (Nasdaq: YDES) أعلنت أن شريكها التجاري EG BioMed حقق اعتماد CAP لمعمله المعتمد CLIA في بوتhell، واشنطن (شهادة CLIA رقم 50D2316600) في 10 أكتوبر 2025. يثبت اعتماد CAP، إلى جانب الشهادة CLIA الحالية، معايير جودة المختبر ويعزز قدرة EG BioMed على تقديم اختبارات مخبرية مطورة (LDTs) متقدمة تدعم برامج الكشف عن سرطان البنكرياس والثدي المعتمدة على المثيلة الحمض النووي في الولايات المتحدة.

وأوضحت YD Bio أن هذا الاعتماد يضع الشركتين في موقع يسمح بتوسيع محفظتهما التشخيصية للكشف المبكر عن السرطان والمراقبة. قدم مدير البحث والتطوير في EG BioMed نتائج جديدة حول مؤشرات حيوية من الحمض النووي الخلوي الحر أثناء AACR (من 28 سبتمبر إلى 1 أكتوبر 2025) ذات صلة بمراقبة سرطان البنكرياس النقيلي.

YD Bio(纳斯达克:YDES)宣布其商业伙伴 EG BioMed 于 2025 年 10 月 10 日在华盛顿州 Bothell 的 CLIA 认证实验室获得 CAP 认证(CAP 证书编号 50D2316600)。CAP 认证与现有的 CLIA 认证共同确认实验室的质量标准,并加强 EG BioMed 提供先进的实验室开发测试(LDTs)的能力,以支持 YD Bio 在美国基于 DNA 甲基化的胰腺癌和乳腺癌检测计划。

YD Bio 指出,这一认证将使两家公司具备扩大诊断组合以进行早期癌症检测和监测的能力。EG BioMed 的研发主管在 AACR(2025 年 9 月 28 日至 10 月 1 日)上展示了新的循环游离 DNA 生物标志物发现,与转移性胰腺癌监测相关。

Positive
  • CAP accreditation secured for EG BioMed Bothell lab (CLIA #50D2316600)
  • Accreditation reinforces ability to deliver LDTs for U.S. market
  • AACR presentation Sept 28–Oct 1, 2025 on novel cfDNA biomarker
Negative
  • None.

Insights

CAP accreditation for EG BioMed strengthens U.S. lab capabilities and supports YD Bio's diagnostic rollout.

EG BioMed earned CAP accreditation for its CLIA-certified Bothell laboratory (CLIA Certificate #50D2316600), which confirms compliance with high laboratory quality standards and formally aligns operational controls with U.S. clinical-testing norms. This accreditation, combined with existing CLIA status, materially increases the laboratory’s credibility to run laboratory-developed tests (LDTs) that the partnership will use to support YD Bio’s DNA methylation cancer-detection programs and related diagnostics.

The main dependencies are documented: sustained CAP compliance, effective LDT validation within that CLIA/CAP framework, and successful integration of the licensed assays into the accredited workflow. Key risks include routine accreditation audits and the need to translate research biomarkers into robust clinical assays under these regulatory and quality systems.

Concrete items to watch include the operational launch and clinical deployment of LDTs from the Bothell lab, any formal test offerings tied to the pancreatic and breast cancer licenses, and follow-up scientific outputs after the AACR presentation on the circulating cell-free DNA biomarker (presented September 28 to October 1, 2025). Expect near-term milestones over the coming months as the lab moves from accreditation to active clinical test delivery.

Taipei, Taiwan, Oct. 10, 2025 (GLOBE NEWSWIRE) -- YD Bio Limited (“YD Bio” or the “Company”) (Nasdaq: YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today announced that its business partner, EG Biomed US Inc. (“EG BioMed”) one of the Company’s licensing partners for pancreatic and breast cancer detection and with 3D Global to develop treatment for eye disorders, has been accredited by the College of American Pathologists’ (CAP) Laboratory Accreditation Program for its CLIA-certified laboratory in Bothell, Washington (CLIA Certificate #50D2316600).

CAP accreditation, widely recognized as the gold standard in laboratory quality assurance, confirms that EG BioMed meets the highest standards of excellence in laboratory operations. Together with its existing CLIA certification, this recognition further strengthens EG BioMed’s ability to deliver advanced laboratory-developed tests (LDTs) in support of YD Bio’s cancer detection programs and diagnostic innovations in the U.S. market.

“We are thrilled to see our partner company, EG BioMed, achieve this prestigious recognition,” said Dr. Ethan Shen, Founder, Chairman and Chief Executive Officer of YD Bio Limited. “CAP accreditation underscores our commitment to improving patient outcomes through scientific innovation and precision, and it strengthens our ability to deliver accurate, reliable diagnostics to patients, and further establishes us as a trusted leader in precision diagnostics. This achievement represents an important step toward our mission of delivering innovative solutions that enhance quality of life and save lives.”

With CAP accreditation secured, YD Bio and EG BioMed are well positioned to expand their diagnostic portfolio, focusing on early cancer detection and monitoring. Along with YD Bio’s ophthalmology products and other breakthrough healthcare solutions, the Company continues to advance its mission to improve patient outcomes and quality of life.

Further underscoring ED BioMed’s scientific leadership, Ruo-Kai Lin, Chief R&D Officer of EG BioMed and Professor of Taipei Medical University, presented new findings at the American Association for Cancer Research (AACR) special Conference on Advances in Pancreatic Cancer Research, held in Boston from September 28 to October 1, 2025. Her presentation highlighted a novel circulating cell-free DNA biomarker with potential to monitor metastasis and disease progression in advanced pancreatic cancer.

About YD Bio Limited

YD Bio Limited is a biotechnology company focused on advancing clinical trials, new drug development, cancer prevention diagnostics, and stem cell and exosome therapies with the potential to transform the treatment of diseases with high unmet medical need. The Company is committed to improving patient outcomes through scientific innovation and precision medicine. In addition to its R&D efforts, YD Bio Limited is a recognized supplier of clinical trial drugs and has expanded into the development and distribution of post-market auxiliary products. For more information, please visit the Company’s website: ir.ydesgroup.com

Forward-Looking Statements

Certain statements in this announcement are forward-looking statements, including, but not limited to, YD Bio’s business plan and outlook. These forward-looking statements involve known and unknown risks and uncertainties and are based on YD Bio’s current expectations and projections about future events that YD Bio believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. YD Bio undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although YD Bio believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and YD Bio cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in YD Bio’s registration statement and other filings with the U.S. Securities and Exchange Commission.

For investor and media inquiries, please contact:
YD Bio Limited
Investor Relations
Email: investor@ydesgroup.com


FAQ

What did YD Bio announce about EG BioMed on October 10, 2025?

YD Bio announced EG BioMed achieved CAP accreditation for its Bothell, Washington CLIA lab (CLIA #50D2316600) on October 10, 2025.

How does EG BioMed’s CAP accreditation affect YD Bio (YDES)?

The accreditation strengthens EG BioMed’s quality credentials and supports delivery of LDTs for YD Bio’s U.S. cancer detection programs.

Which tests will EG BioMed support for YD Bio after accreditation?

EG BioMed will support advanced laboratory-developed tests related to YD Bio’s pancreatic and breast cancer detection programs.

Where is EG BioMed’s accredited laboratory located for YD Bio testing?

The CAP-accredited, CLIA-certified laboratory is located in Bothell, Washington (CLIA #50D2316600).

Did EG BioMed present new scientific data recently and when?

Yes. EG BioMed’s Chief R&D Officer presented findings on a novel circulating cell-free DNA biomarker at AACR from September 28 to October 1, 2025.

What is the potential impact of accreditation on YD Bio’s U.S. diagnostics strategy?

The accreditation may enable expanded U.S. deployment of diagnostic LDTs and support YD Bio’s focus on early cancer detection and monitoring.
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